The invention relates to the field of fluid management systems and, more particularly, to an endoscope distention fluid management assembly for use in an endoscopic operative procedure, such as a hysterectomy procedure.
The occurrence of surgical procedures which require medical instruments which use fluid irrigation to ensure visualization of the operative area continues to increase over time. One such medical procedure is a hysteroscopic procedure in which a hysteroscope is used to provide fluid irrigation for permitting visualization of the uterine area. Operative hysteroscopy uses pressurized solutions to distend the operative space (the uterus) so that the clinician can clearly identify the anatomy and subsequently remove the diseased tissue during the operative procedure. Over the duration of the surgical procedure, an individual, such as a nurse, measures the amount of fluid being delivered to the patient and the amount of fluid which is recovered from the patient during the procedure. If the amount of fluid being recovered from the patient is less than the amount of fluid being delivered to the patient, a fluid deficit results.
A fluid deficit may result due to any number of reasons including but not limited to the occurrence of fluid loss which results from leakage through a cervical seal as well as fluid loss through an outflow port of the hysteroscope. Since fluid monitoring is a very important part of managing the patient during the operative procedure, all fluids exiting the uterus must be balanced with the fluids entering the organ so as to maintain an account of the occurrence of any fluid deficit during the procedure. In addition, it is important to monitor whether a fluid imbalance occurs as a result of the patient absorbing an excessive quantity of fluid. If a patient absorbs an excessive quantity of fluid, complications can result including those of a serious nature. Therefore, it is important to continuously monitor the fluids in the operative space during the operative procedure to ensure that the uterus is properly distended to permit sufficient visualization thereof and to ensure that the patient""s health is not jeopardized.
Typically, the clinician will use a fluid collection system as the surgical procedure is being performed so that fluid may be recovered and collected from the operative site. As previously mentioned, the endoscope contains an outflow port in which fluid is transferred from the uterus to a remote location where it is collected in a receptacle and then measured to ascertain the total fluid loss of the patient during the procedure. During the procedure, a hysteroscopy pouch drape or the like is typically used and is disposed underneath the patient""s buttocks area. This drape is designed to collect any fluid which may be discharged from the uterus during the procedure. The fluid is caught in a pouch portion and is collected therein for delivery to the remote collection receptacle. The drape and more specifically the pouch portion thereof is also likewise connected to the collection receptacle by means of a fluid carrying device such as attachable tubing which permits the fluid to be effectively transferred to the collection receptacle.
Now referring to FIG. 1 which illustrates a conventional fluid management assembly, generally designated at 10. The collection system 10 comprises a first fluid carrying member 12 which is connected at a first end 14 to a first connector 16 which is designed to engagingly mate with the outflow port of the hysteroscope (not shown). A second end 17 of the first fluid carrying member 12 is connected to a Y-connector 18 and more specifically is connected to a first leg 20 thereof. The management assembly 10 further includes a second fluid carrying member 22 which is coupled to the hysteroscopy pouch drape (not shown) at a first end 24 thereof. The first end 24 preferably has a second connector 26 coupled thereto which is designed to permit attachment of the second fluid carrying member 22 to the hysteroscopy pouch drape. A second end 28 of the second fluid carrying member 22 is connected to a second leg 30 of the Y-connector 18 with the first and second legs 20, 30 being in parallel orientation relative to one another.
The Y-connector 18 also includes a main leg 32 which extends in an opposite direction relative to the first and second legs 20, 30. The main leg 32 receives and is coupled to a main fluid carrying member 34 which receives fluid from both the first and second fluid carrying members 12, 22 and directs the fluid to a suction source (not shown). It will be appreciated that the suction source serves to supply a sufficient suction force so that the fluid is drawn through all the members 12, 22, 34 and is delivered to the collection receptacle (the suction source). Preferably, the first, second, and third fluid carrying members 12, 22, 34, respectively, comprise tubing which is suitable for use in the intended medical procedures described herein. At the end of the procedure, the total volume of the fluid collected in the collection receptacle is reconciled with the total input volume and a fluid deficit, if any, is calculated for the patient.
The management assembly 10 also preferably includes a pinch clamp 36 which is disposed about the first fluid carrying member 12 and is designed to selectively restrict the flow rate of fluid through the first carrying member 12. The illustrated pinch clamp 36 includes a ratchet mechanism which is designed to pinch the first fluid carrying member 12 between a pair of protuberances, generally indicated at 38. As the pinch clamp 36 is manipulated so that the first fluid carrying member 12 is further constricted between the protuberances 38, the flow rate of the fluid decreases.
The management assembly 10 also preferably further includes a flow restrictor (not shown) which is coupled to the first end 24 of the second fluid carrying member 22. The hysteroscopy pouch drape does not always contain fluid and when this condition exists, the Y-connector 18 is vented to atmosphere which reduces the suction applied to the endoscope line (the first fluid carrying member 12). By being inserted into the second fluid carrying member 22, the flow restrictor 39 is designed to enhance the suction in the endoscope line so that the fluid is properly drawn from the hysteroscope whether or not fluid is present in the drape.
While suitable for its intended purpose, the above-described conventional management assembly 10 has associated disadvantages which result in reduced uterine distention. Because uterine distention is dependent upon on both inflow and outflow performance, optimization of the fluid inflow and outflow will result in uterine distention being likewise optimized. During distention of the uterus, fluid is pumped into the uterine space to develop positive pressure which is required in order to increase the volume of the uterine space. The fluid pumped into the uterine space is delivered by means of the hysteroscope which has an inflow port along with the aforementioned outflow port. Fluid which enters the uterine space through the inflow port is then relieved through the outflow port. When the fluid is relieved through the outflow port, it is permitted to flow under gravity into the hysteroscopy pouch drape for subsequent aspiration into the collection receptacle.
During gravity flow from the outflow port, the fluid flows through a vertical length of the first fluid carrying member 12 which creates a siphon effect. The magnitude of the siphon effect will depend upon the length of the first fluid carrying member 12 which hangs below the uterus of the patient. This siphon effect acts as a negative pressure which serves to reduce the positive pressure acting within the uterine cavity and hence, reduces the amount of uterine distention. This reduction in distention, if significant enough, can slow down the surgical procedure and result in an increase in bleeding which in turn results in a reduction in visibility of the anatomy.
Another associated disadvantage of the conventional system is that often suction is applied directly to the outflow port of the hysteroscope and during this type of application high levels of suction may be applied to the uterus and hence reduce the distention thereof. This results in the same above-mentioned difficulties being experienced and generally complicates the surgical procedure. In addition, the Y-connector 18, as previously described, serves to receive both the fluids from the first and second fluid carrying members 12, 22 under suction so that all of the patient""s fluids may be pooled into one collection canister (the collection receptacle). Using a Y-connector arrangement can result in a decrease in performance since the system flow needs to be mechanically balanced to allow adequate simultaneous entrainment from both the first and second legs 20, 30 of the Y-connector 18. If the first and second legs 20, 30 are not balanced, flow may be biased to one of the first and second legs 20, 30 because the fluid seals the leg with less resistance causing a sumping action to occur. The occurrence of a sumping action results in cycling of intrauterine pressures, uterine bleeding and increases surgical procedure time. For example, when there is a fluid build-up in the hysteroscopy pouch drape, the drape acts as a reservoir creating a column of fluid in the second fluid carrying member 22. Because of the column of fluid, the pressure in the second fluid carrying member 22 is increased and this may create a fluid seal which limits the fluid flow through the first fluid carrying member 12 (endoscope line). This causes a recycling of the intrauterine pressure which is undesirable.
Therefore, there is need for an improved management assembly for use in an endoscopic, e.g., hysteroscopic, surgical procedure which permits the operative organ to be optimally distended during the entire surgical procedure. The management assembly of the present invention satisfies these and other needs.
The present invention concerns improvements in fluid management assemblies for use in endoscopic procedures. According to the present invention, it has been discovered that locating the Y-connector so as to elongate the scope and drape legs results in improved distention and eliminates the deficiencies associated with the conventional designs. Specifically, the Y-connector is positioned so that the Y-connector is in proximate relationship with the suction canister which provides suction forces and collects the fluid. Because the Y-connector is proximately located relative to the suction source, the Y-connector is exposed to a greater suction force. Furthermore, the elongation of the scope and drape legs of the present assembly results in minimal mixing of the fluids and minimizes the dependency between the lines. By delivering the fluids further downstream before they are combined at the Y-connector and by subjecting the Y-connector to a greater suction force, pooling of fluid within the Y-connector is avoided. As will be described in greater detail hereinafter, the position of the Y-connector eliminates pooling since the fluid is entrained upwardly into the Y-connector in comparison with the conventional design in which the fluid is entrained downwardly. The present assembly also eliminates or substantially reduces the likelihood that a liquid seal will occur in the Y-connector resulting in flow restriction within the endoscopic line because the present design permits the pressure within the endoscopic and drape lines to be substantially balanced.
The arrangement of the Y-connector relative to the scope and drape legs also eliminates the need for a flow restrictor in the drape line yet provides adequate suction on the endoscope when the drape is empty. Accordingly, any pressure fluctuations in the uterus are eliminated and flow is enhanced when fluid is aspirated simultaneously from the drape and the scope.